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Bharat Biotech's Covaxin Gets Approval For Phase 2/3 Trials On Children Aged 2 To 18

The trial will be conducted in 525 subjects at different locations, including AIIMS Patna, AIIMS Delhi and Meditrina Institute of Medical Sciences in Nagpur.

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The Central Drugs Standard Control Organization’s (CDSCO) Subject Expert Committee on COVID-19 met on Tuesday have a discussion about Bharat Biotech’s application to perform phase 2/3 clinical trials on children in the age group 2 to 18 years to assess the efficacy, immunogenicity and reactogenicity of Covaxin jabs. Covaxin, a COVID-19 vaccine developed by Hyderabad's Bharat Biotech has received clearance from an expert panel to perform the phase 2 and 3 trials on children aged between 2 to 18 years.

On Tuesday, an expert panel (Subject Expert Committee) recommended the drug maker’s anti-COVID vaccine for phase 2 and 3 clinical trials on children aged two to eighteen years, as per the news agency PTI.

The trial will be conducted in 525 subjects at different locations, including AIIMS Patna, AIIMS Delhi and Meditrina Institute of Medical Sciences in Nagpur, as per the official sources.

The Central Drugs Standard Control Organization’s (CDSCO) Subject Expert Committee on COVID-19 met on Tuesday to discuss Bharat Biotech’s application to perform phase 2 and 3 clinical trials in children aged 2 to 18 years to assess the efficacy, immunogenicity and reactogenicity of Covaxin jabs.

The idea had earlier been discussed at an SEC meeting on 24th February and the company had been asked to request a revised clinical trial protocol.